The study is being done with people who are taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen are not doing a good job of fighting their HIV infection.

The main purpose of this study is to compare two other anti-HIV drug regimens to see how well they fight HIV. The study will also see how well participants tolerate the drug regimens and how safe they are.

The study will determine whether taking the combination of lopinavir/ritonavir (LPV/r) plus raltegravir (RAL) works as well as what usually is used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination. Testing a regimen that does not include any NRTI is important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.

HIV-1 drug resistance mutations in gag, protease, reverse transcriptase, and integrase in participants with virologic failure at baseline and at time of virologic failure [ Time Frame: Through to week 96 ] [ Designated as safety issue: No ]

Time to first Grade 3 or higher Adverse Event (AE) that is at least one grade higher than baseline [ Time Frame: Through to week 96 ] [ Designated as safety issue: Yes ]

Time to discontinuation of randomized treatment for toxicity [ Time Frame: Through to week 96 ] [ Designated as safety issue: Yes ]

Time to discontinuation of randomized treatment for toxicity (including participant decision to discontinue for low grade toxicity); within class NRTI changes are not considered an endpoint.

Time to new AIDS-defining events, death and targeted serious non-AIDS-defining events [ Time Frame: Through to week 96 ] [ Designated as safety issue: Yes ]

Duration of hospitalizations [ Time Frame: Through to week 96 ] [ Designated as safety issue: No ]

Participants will be administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs (listed below) until the participant reaches 96 weeks of follow-up-

Certain laboratory values obtained within 45 days prior to study entry. More information on this criterion can be found in the study protocol.

Negative pregnancy test within 48 hours prior to study entry.

Must refrain from participating in a conception process, and, if participating in sexual activity that could lead to pregnancy, must use at least one acceptable type of contraceptive. More information on this criterion can be found in the study protocol.

Ability and willingness of participant or legal guardian/representative to provide informed consent.

No intention to relocate away from current geographical area of residence for the duration of study participation.

Exclusion Criteria:

Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days prior to study entry, with the exception of a tapering course of corticosteroids as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic obstructive pulmonary disease flare and/or prednisone at a daily dose of <10 mg (physiologic replacement dose).

If the potential participant has had resistance testing, evidence of broad NRTI cross-resistance that, in the opinion of the investigator, would not allow selection of an effective NRTI combination if the participant were randomized to the LPV/r + best available NRTIs arm.

Prior exposure to a Protease Inhibitor.

Known history of congenital long QT syndrome, hypokalemia, or planned use of other drugs that prolong the QT interval.

Pregnancy or breast-feeding.

Known history of chronic hepatitis B virus (HBV) infection or current HBV infection defined by the presence of hepatitis B surface antigen in serum or plasma.

Requirement for taking any medications that are prohibited with the study drugs. More information on this criterion can be found in the study protocol, section 5.4.

Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.

Active drug or alcohol use or dependence or other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352715